Method for generating a microbial deactivation fluid in an apparatus for deactivating instruments and devices

ABSTRACT

A method of generating a microbial deactivation fluid to circulate through an apparatus that has a decontamination chamber for holding medical instruments and devices, comprising the steps of:
         (a) providing a first compartment and a second compartment in the circulation system;   (b) providing a chemical reagent in the first compartment and a builder composition in the second compartment;   (c) causing a fluid to flow through the second compartment to mix with the builder composition to create an alkaline fluid;   (d) when the alkaline fluid has reached a predetermined pH level, causing the alkaline fluid to flow through the first compartment to mix with the chemical reagent to dissolve the chemical reagent to generate a microbial deactivation fluid; and   (e) continuing steps (c) and (d) to continue the generation of the microbial deactivation fluid.

FIELD OF THE INVENTION

The present invention relates to disinfection or deactivation ofmedical, dental, pharmaceutical, veterinary or mortuary instruments anddevices, and more particularly, to a method and apparatus fordeactivating items and for maintaining such items in a deactivatedstate.

BACKGROUND OF THE INVENTION

Medical, dental, pharmaceutical, veterinary or mortuary instruments anddevices are routinely exposed to blood or other body fluids duringmedical procedures. Following such procedures, a thorough cleaning andanti-microbial deactivation of the instruments is required beforesubsequent use. Liquid microbial deactivation systems are now widelyused to clean and deactivate instruments and devices that cannotwithstand the high temperature of a steam deactivation system. Liquidmicrobial deactivation systems typically operate by exposing the medicaldevices and/or instruments to a liquid disinfectant or a deactivationcomposition, such as peracetic acid or some other strong oxidant. Insuch systems, the instruments or devices to be cleaned are typicallyplaced within a deactivation chamber within the deactivation system, orin a container that is placed within the deactivation chamber. During adeactivation cycle, a liquid disinfectant is then circulated through thedeactivation chamber (and the container therein).

The present invention provides a method and apparatus for microbiallydeactivating medical instruments and devices.

SUMMARY OF THE INVENTION

In accordance with the present invention, there is provided in anapparatus for deactivating medical instruments and devices having acirculation system for circulating a fluid through a decontaminationchamber for holding medical instruments and devices, a method ofgenerating a microbial deactivation fluid and exposing the devices tothe microbial deactivation fluid comprising the steps of:

(a) providing a first compartment and a second compartment in thecirculation system;

(b) providing a chemical reagent in a first compartment and a buildercomposition in a second compartment;

(c) causing a fluid to flow through the second compartment to mix withthe builder composition to create an alkaline fluid;

(d) when the alkaline fluid has reached a predetermined pH level,causing the alkaline fluid to flow through the first compartment to mixwith the chemical reagent to dissolve the chemical reagent to generate amicrobial deactivation fluid;

(e) continuing steps (c) and (d) to continue the generation of themicrobial deactivation fluid; and

(f) when the microbial deactivation fluid has reached a minimumpredetermined concentration, causing the microbial deactivation fluid toflow through the decontamination chamber.

In accordance with another aspect of the present invention, there isprovided in an apparatus for deactivating medical instruments anddevices having a circulation system for circulating a fluid through adecontamination chamber for holding medical instruments and devices, amethod of generating a microbial deactivation fluid comprising the stepsof:

(a) providing a first compartment and a second compartment in thecirculation system;

(b) providing a chemical reagent in a first compartment and a buildercomposition in a second compartment;

(c) causing a fluid having a temperature between about 45° C. and about60° C. to flow through the second compartment to mix with the buildercomposition to create an alkaline fluid;

(d) when the alkaline fluid has reached a predetermined pH level,causing the alkaline fluid to flow through the first compartment to mixwith the chemical reagent to dissolve the chemical reagent to generate amicrobial deactivation; and

(e) continuing steps (c) and (d) to continue the generation of themicrobial deactivation fluid.

In accordance with yet another aspect of the present invention, there isprovided in an apparatus for deactivating medical instruments anddevices having a circulation system for circulating a fluid through adecontamination chamber for holding medical instruments and devices, amethod of generating a microbial deactivation fluid comprising the stepsof:

(a) providing a first compartment and a second compartment in thecirculation system;

(b) providing a chemical reagent in the first compartment and a buildercomposition in the second compartment;

(c) causing a fluid to flow through the second compartment to mix withthe builder composition to create an alkaline fluid;

(d) when the alkaline fluid has reached a predetermined pH level,causing the alkaline fluid to flow through the first compartment to mixwith the chemical reagent to dissolve the chemical reagent to generate amicrobial deactivation fluid; and

(e) continuing steps (c) and (d) to continue the generation of themicrobial deactivation fluid.

In accordance with still another aspect of the present invention, thereis provided in an apparatus for deactivating medical instruments anddevices having a circulation system for circulating a fluid through adecontamination chamber for holding medical instruments and devices, amethod of generating a microbial deactivation fluid comprising the stepsof:

(a) providing a first compartment and a second compartment in thecirculation system;

(b) providing a chemical reagent in the first compartment and a buildercomposition in the second compartment;

(c) causing a fluid to flow through the second compartment to mix withthe builder composition to create an alkaline fluid;

(d) after a predetermined amount of time, causing the alkaline solutionto flow through the first compartment to mix with the chemical reagentto dissolve the chemical reagent to generate a microbial deactivationfluid; and

(e) continuing steps (c) and (d) to continue the generation of themicrobial deactivation fluid.

One advantage of the present invention is an apparatus for deactivatingmedical instruments and items.

Another advantage of the present invention is a container for holdingmedical instruments and items during a microbial deactivation process,which container maintains the instruments in a deactivated environmenttherein for a prolonged period of time after removal of the containerfrom the apparatus.

A still further advantage of the present invention is a container asdescribed above that may be used as a storage device for storing themicrobially deactivated instruments.

Another advantage of the present invention is a compact, front-loadingapparatus for deactivating medical instruments and items.

A still further advantage of the present invention is an apparatus asdescribed above having a drawer system that opens at a downward angle toa user.

Another advantage of the present invention is an apparatus fordeactivating medical instruments and items having a circulation systemthat allows for separate rinsing of a chemistry container that is usedto generate a microbial deactivation fluid.

A still further advantage of the present invention is an apparatus fordeactivating medical instruments and items having a chemistry containerthat can be easily modified to accommodate different chemistries.

A still further advantage of the present invention is an apparatus fordeactivating medical instruments and items that utilizes an instrumentcontainer that can be configured to include different instruments anddevices.

Another advantage of the present invention is an apparatus fordeactivating medical instruments and items that circulates adeactivation fluid through sterile water filters to prevent the growthof microorganisms on filter membrane.

Another advantage of the present invention is an apparatus fordeactivating medical instruments and items that utilizes a two-part drychemistry.

A still further advantage of the present invention is an apparatus fordeactivating medical instruments and items that utilizes a chemistrycontainer that has a connector-less design.

A still further advantage of the present invention is an apparatus fordeactivating medical instruments and items having a high-pressure zoneand a low-pressure zone to induce constant flow of deactivation fluidthrough the apparatus.

A still further advantage of the present invention is a method forquickly generating a microbial deactivation fluid from dry chemistry.

These and other advantages will become apparent from the followingdescription of a preferred embodiment taken together with theaccompanying drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may take physical form in certain parts and arrangement ofparts, a preferred embodiment of which will be described in detail inthe specification and illustrated in the accompanying drawings whichform a part hereof, and wherein:

FIG. 1 is a perspective view of an automated reprocessor for microbiallydeactivating medical instruments, according to the present invention;

FIG. 2 is a perspective view of the reprocessor of FIG. 1, showing amovable drawer in an opened position and an instrument container removedtherefrom, and also showing an access panel to a chemistry deliverysystem in an opened position and a chemistry container removertherefrom;

FIG. 3 is a side, elevational view of the reprocessor of FIG. 1, showingthe reprocessor on a counter top relative to a user;

FIG. 4 is a schematic diagram of the reprocessor shown in FIG. 1;

FIG. 5 is a schematic diagram of the reprocessor, illustrating the pathof fluids through the reprocessor during a reprocessor fill phase;

FIG. 6 is a schematic diagram of the reprocessor, illustrating the pathof fluids through the reprocessor during a system circulate phase;

FIG. 7 is a schematic diagram of the reprocessor, illustrating the pathof fluids through the reprocessor during a chemistry generation phase;

FIG. 8 is a schematic diagram of the reprocessor, illustrating the pathof fluids through the reprocessor during an instrument exposure phase;

FIG. 9A is a schematic diagram of the reprocessor, illustrating the pathof fluids through the reprocessor during a first part of a drain phase;

FIG. 9B is a schematic diagram of the reprocessor, illustrating the pathof fluids through the reprocessor during a second part of the drainphase;

FIG. 10 is a sectional view of a filter element from the reprocessorshown in FIG. 1;

FIG. 11 is a sealed package containing a chemistry-holding device thatis used in the reprocessor shown in FIG. 1;

FIG. 12 is a sectional view taken along lines 12-12 of FIG. 11;

FIG. 13 is a sectional view of a chemistry-delivery system used in thereprocessor shown in FIG. 1, showing the chemistry-delivery system in anopen position;

FIG. 14 is a sectional view taken along lines 14-14 of FIG. 13;

FIG. 15 is a sectional view taken along lines 15-15 of FIG. 13;

FIG. 16 is a partially sectioned, side-elevational view of thechemistry-delivery system, showing a chemistry-holding device disposedtherein;

FIG. 17 is a sectional view of the chemistry-delivery system inoperation;

FIG. 18 is a cross-sectional view of a drawer assembly from theapparatus show in FIG. 1;

FIG. 19 is an enlarged view, showing a connector assembly for the drawerassembly show in FIG. 18;

FIG. 20 is a sectional view taken along lines 20-20 of FIG. 19;

FIG. 21 is a sectional view taken along lines 21-21 of FIG. 19;

FIG. 22 is a sectional view taken along lines 22-22 of FIG. 19;

FIG. 23 is a partially sectioned view of the connector assembly shown inFIG. 19;

FIG. 24 is a top plan view of an instrument storage container used inthe apparatus shown in FIG. 1;

FIG. 25 is a sectional view taken along lines 25-25 of FIG. 24, showinga valve assembly in an opened position;

FIG. 26 is a sectional view of the valve assembly shown in FIG. 25,showing the valve assembly in a closed position;

FIG. 27 is a sectional view taken along lines 27-27 of FIG. 24, showinga seal arrangement on the instrument storage container;

FIG. 28 is a perspective view of a storage cabinet for storingdecontaminated instrument containers, illustrating another aspect of thepresent invention;

FIG. 29A is a sectional view of an alternate embodiment of a valveassembly, showing the valve assembly in a first position;

FIG. 29B is a partially sectioned view of the valve assembly of FIG.29A, showing the valve assembly in a second position;

FIG. 29C is partially section view taken along lines 29C-29C of FIG.29B, showing a filter element; and

FIG. 29D is a perspective view of the filter element.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT

Referring now to the drawings wherein the showings are for the purposeof illustrating a preferred embodiment of the invention only, and notfor the purpose of limiting same, FIG. 1 shows an apparatus 10 formicrobially deactivating medical instruments and other devices,illustrating a preferred embodiment of the present invention. Apparatus10 is designed to rest upon a table or countertop 12, as illustrated inFIG. 1. Countertop 12 in and of itself forms no part of the presentinvention. Apparatus 10 includes a housing structure 22 containing theoperative components of apparatus 10. Housing structure 22 has an uppersurface 24 that slopes generally downward toward a front face 26. Frontface 26 has an upper section 26 a and a lower section 26 b. Uppersection 26 a includes a display panel 28. Display panel 28 is connectedto a controller system (not shown) that controls the operation ofapparatus 10.

A drawer assembly 600 has a front face panel 634 that is coplanar withlower section 26 b of front face 26 when drawer assembly 600 is in aclosed position, as illustrated in FIG. 1. A drawer actuation button 636is provided on front panel 634 of drawer assembly 600. Drawer assembly600 is movable from a closed position, as shown in FIG. 1, to an openedposition, as illustrated in FIG. 2. Drawer assembly 600 includes adrawer tray 622 having a flat upper surface 632. A recess or cavity 624is formed in tray 622, as illustrated in FIG. 2. Surface 632 extendsaround the periphery of recess or cavity 624. Cavity 624 is dimensionedto receive an instrument container 800. Container 800 is provided toreceive the instruments or devices to be deactivated. Container 800 isdimensioned to be received within cavity 624, as illustrated in FIG. 2.

A small, rectangular access panel 22 a is formed in housing structure22. In the embodiment shown, access panel 22 a is formed to the rightside of display panel 28 in a recess formed in housing structure 22.Access panel 22 a is movable between a closed position, shown in FIG. 1,and an opened position, shown in FIG. 2. In its opened position, accesspanel 22 a allows access to a chemistry-delivery system 400 that shallbe described in greater detail below. Chemistry-delivery system 400 isdimensioned to receive a chemistry-holding device 430 that contains drychemicals that, when combined with water, form a microbial deactivationfluid used in apparatus 10. As best illustrated in FIG. 3, drawerassembly 600 opens in a generally downward direction. In other words,drawer assembly 600 slides into and out of housing structure 22 in aplane that is sloping downwardly relative to the housing structure 22.

Referring now to FIG. 4, a simplified, schematic piping diagram ofapparatus 10 is shown. As schematically illustrated in FIG. 3, drawerassembly 600 includes a drive assembly 650, including a rack 658 and apinion gear 656. Rack 658 is connected to drawer assembly 600 and ismovable by pinion gear 656 that is driven by a motor 652. In FIG. 4,instrument container 800 is shown disposed within cavity 624 defined bydrawer tray 622. When drawer assembly 600 is in the closed position, asshown in FIG. 4, drawer tray 622 is disposed beneath a plate 642. Astatic seal element 644 is disposed on the bottom side of plate 642 forcontact with the planar portion of drawer tray 622. In this respect,static seal 644 is generally continuous about the periphery of cavity624 in drawer tray 622. An air-inflatable bladder 646 is provided on thetop side of plate 642 to force plate 642 and static seal 644 intosealing engagement with the planar portion of drawer tray 622.Inflatable bladder 646 is disposed between the upper surface of plate642 and housing structure 22 to force plate 642 into sealing engagementwith drawer tray 622. A plurality of springs 647 (best shown in FIG. 18)are connected at one end to the upper side of plate 642 and at the otherend to housing structure 22. Springs 647 are tension springs that biasplate 642 and static seal 644 away from the planar portion of drawertray 622.

As schematically illustrated in FIG. 4, when instrument container 800 isdisposed within the recess 624 in drawer tray 622, instrument container800 is connected to fluid inlet lines and a drain line of a fluidcirculation system 100. Instrument container 800 is also incommunication with an air conduit 826 for inflating a seal 824 disposedbetween a tray 812 and a lid 912 of instrument container 800, as shallbe described in greater detail below. When drawer assembly 600 is in aclosed position and inflatable bladder 646 is activated to force staticseal 644 into contact with the planar portion of drawer tray 622, adecontamination chamber is formed within apparatus 10, as schematicallyillustrated in FIG. 4. Fluid circulation system 100 provides microbialdeactivation fluid to the deactivation chamber and is further operableto circulate the microbial deactivation fluid through thedecontamination chamber, through instrument container 800 and throughinstruments contained within instrument container 800.

To enable drawer assembly 600 and drawer tray 622 to move into and outof housing structure 22 of apparatus 10, the input lines and the drainlines from fluid circulation system 100 are attachable and detachablefrom drawer tray 622 by means of a connector assembly 660 that shall bedescribed in greater detail below.

Fluid circulation system 100 includes a water inlet line 102 that isconnected to a source of heated water (not shown). A valve 104 isdisposed within water inlet line 102 to control the flow of water intoapparatus 10. A pair of macro filters 106, 108 are provided in waterinlet line 102 downstream from valve 104 to filter large contaminantsthat may exist in the incoming water. A flow restrictor 112 is disposedin water inlet line 102 to regulate the flow of water therethrough. Anultraviolet (UV) treatment device 114 for deactivating organisms withinthe water source is preferably provided in water inlet line 102. A watervalve 116 controls the flow of water from water inlet line 102 to asystem feeder line 122. System feeder line 122 includes a filter element300 to filter microscopic organisms from the incoming water source toprovide sterile water to fluid circulation system 100.

System feeder line 122 splits into a first branch feeder line 124 and asecond branch feeder line 126 downstream of filter element 300. Firstbranch feeder line 124 extends from system feeder line 122, asschematically illustrated in FIG. 4. A heater element 132 is disposedwithin first branch feeder line 124. A first temperature sensor 134 isdisposed within first branch feeder line 124 upstream of heater element132. First temperature sensor 134 is operable to provide signals to thesystem controller indicative of the temperature of the water upstream ofheater element 132. A second temperature sensor 136 is attached to firstbranch feeder line 124 downstream of heater element 132 to providetemperature measurements of water downstream of heater element 132.Second temperature sensor 136 is operable to provide signals to thesystem controller indicative of the temperature of the water downstreamof heater element 132. A sterilant sensor 142 is disposed within firstbranch feeder line 124. Sterilant sensor 142 is operable to providesignals to the system controller indicative of the concentration of asterilant flowing within first branch feeder line 124. A conductivityprobe 144 is attached to first branch feeder line 124 downstream ofsterilant sensor 142. Conductivity probe 144 is operable to providesignals to the system controller indicative of the conductivity of thewater in first branch feeder line 124. First branch feeder line 124includes a branch section 124 a that extends through the plate in thedrawer assembly to communicate with the recess or cavity defined by thedrawer tray. A drain line 146 is also connected to first branch feederline 124 upstream of sterilant sensor 142. A valve 147 is disposedwithin drain line 146 to control the flow of fluid through drain line146.

Second branch feeder line 126 also connects to the connector assembly660. A pressure sensor 148 is disposed within second branch feeder line126. Pressure sensor 148 is capable of measuring the pressure of thefluid in second branch feeder line 126 and providing a signal that isproportional to the measured pressure to the system controller. An airline 152 is connected to second branch feeder line 126, as illustratedin FIG. 4. Air line 152 is connected to a source (not shown) of dry air.A filter 154 is disposed within air line 152. A directional valve 156 isdisposed within air line 152. Directional valve 156 is arranged to allowair to be forced into second branch feeder line 126, but to preventwater or fluids within second branch feeder line 126 from flowing towardthe source of air. A valve 158 is disposed within second branch feederline 126, between pressure sensor 148 and where air line 152 connects tosecond branch feeder line 126.

A return line 162 is connected at one end to the connector assembly 660.The other end of return line 162 has a first branch 162 a that connectsto the inlet side of a pump 172. Pump 172 is preferably a high pressure,low volume pump, as shall be described in greater detail below. Pump 172preferably is a positive displacement pump that is capable of pumpingbetween about 2 gallons per minute and about 6 gallons per minute. Inone embodiment, pump 172 is capable of pumping between about 4 gallonsper minute and about 5 gallons per minute. In another embodiment pump172 is capable of pumping about 3.5 gallons per minute. Pump 172 iscapable of pumping between about 20 psig and about 60 psig of fluidpressure. In one embodiment, pump 172 is capable of pumping betweenabout 30 psig and about 50 psig of fluid pressure. In anotherembodiment, pump 172 is capable of pumping about 40 psig of fluidpressure. The outlet side of pump 172 defines the beginning of systemfeeder line 122. A valve 164 is disposed within system feeder line 122between pump 172 and the location where water inlet line 102 joins tosystem feeder line 122. A drain line 166 is connected to return line162. A valve 168 is disposed within drain line 166 to control the flowof fluid therethrough.

Return line 162 includes a second branch 162 b that connects to theinlet side of a pump 182. Pump 182 is a high volume pump. Pump 182preferably is a centrifugal pump that is capable of pumping betweenabout 7 gallons per minute and about 15 gallons per minute at betweenabout 5 psig and about 14 psig of fluid pressure. In one embodiment,pump 182 pumps between about 8 gallons per minute and about 12 gallonsper minute at between about 7 psig and about 12 psig of fluid pressure.In another embodiment, pump 182 pumps about 10 gallons per minute atabout 9 psig of fluid pressure.

Pump 172 pumps between about 10% and about 46% of the total fluid flowin the system and pump 182 pumps between about 54% and about 90% of thetotal fluid flow in the system. In one embodiment, pump 172 pumpsbetween about 20% and about 35% of the total fluid flow in the systemand pump 182 pumps between about 65% and about 80% of the total fluidflow in the system. In another embodiment, pump 172 pumps about 25% ofthe total fluid flow in the system and pump 182 pumps about 75% of thetotal fluid flow in the system. The outlet side of pump 182 is connectedto an auxiliary system feeder line 184 that is connected to first branchfeeder line 124. A pressure sensor 186 is disposed within auxiliarysystem feeder line 184 at a location preceding the juncture whereauxiliary system feeder line 184 connects with first branch feeder line124. Pressure sensor 186 is capable of measuring the pressure of thefluid in auxiliary system feeder line 184 and providing a signal that isproportional to the measured pressure to the system controller. A valve125 is disposed in first branch feeder line 124 to control fluid flow inbranch feeder line 124. Valve 125 is disposed at a location upstream ofthe juncture where auxiliary system feeder line 184 connects with firstbranch feeder line 125. When valve 125 is in a first position, betweenabout 75% and about 100% of the flow in branch feeder line 124 is cableof flowing into auxiliary feeder line 184. In one embodiment, betweenabout 90% to about 100% of the flow in branch feeder line 124 is cableof flowing into auxiliary feeder line 184. In another embodiment, about100% of the flow in branch feeder line 124 is cable of flowing intoauxiliary feeder line 184. When valve 125 is in a second positionbetween about 5% to about 25% of the flow in branch feeder line 124 iscable of flowing into auxiliary feeder line 184. In one embodiment,between about 5% and about 10% of the flow in branch feeder line 124 iscable of flowing into auxiliary feeder line 184. In another embodiment,about 5% of the flow in branch feeder line 124 is cable of flowing intoauxiliary feeder line 184.

A filter bypass line 192 communicates with system feeder line 122 onopposite sides of filter element 300. Specifically, one end of bypassline 192 is connected to system feeder line 122 between pump 172 andvalve 164. The other end of bypass line 192 communicates with systemfeeder line 122 downstream of filter element 300, but before thejuncture where system feeder line 122 splits into first branch feederline 124 and second branch feeder line 126. As shown in FIG. 4, a valve194 is disposed between filter element 300 and downstream of theconnection of bypass line 192 to system feeder line 122. A drain line196 is connected to system feeder line 122 between valve 194 and filterelement 300. A valve 198 is disposed within drain line 196 to regulateflow therethrough. A drain line 328 is also connected to filter element300. A valve 327 is disposed within drain line 328 to control the flowof fluid therethrough. A temperature sensor 332 is connected to filterelement 300. Temperature sensor 332 is capable of measuring thetemperature of the fluid in filter element 300 and providing a signalthat is proportional to the measured temperature to the systemcontroller. A pressure sensor 334 is also connected to filter element300. Pressure sensor 334 is capable of measuring the pressure of thefluid in filter element 300 and providing a signal that is proportionalto the measured pressure to the system controller.

A test line 212 is connected to filter element 300 to conduct integritytests of filter element 300. As illustrated in FIG. 4, one end of testline 212 is connected to filter element 300 and the other end isconnected to a drain. Two spaced-apart valves 214, 216 are disposed intest line 212. Between valves 214 and 216, a first test line section 212a is defined. Between valve 216 and filter element 300, a second testline section 212 b is defined. An air line 222 from a source ofpressurized, filtered, clean air is connected to test line 212. Air line222 is connected to test line section 212 a between valves 214, 216. Acheck valve 224 is disposed in air line 222. Check valve 224 is arrangedto allow one-way flow of air to test line section 212 a. A pressuresensor 226 is disposed in test line section 212 a between valves 214,216 to measure the air pressure in test line section 212 a and provide asignal that is proportional to the measured air pressure in test line tothe system controller. First test line section 212 a includes aT-fitting 232 for connecting first test line section 212 a to one sideof a differential pressure sensor 234. A valve 236 is disposed inT-fitting 232 to control connection of first test line section 212 a todifferential pressure sensor 234. A second T-fitting 242 is disposed insecond test line section 212 b and is connected to a second side ofdifferential pressure sensor 234. Differential pressure sensor 234 iscable of the measuring the difference in the pressure of the fluid onone side of differential pressure sensor 234 and pressure on the secondside of differential pressure sensor 234. Differential pressure sensoris then capable of providing a signal that is proportional to themeasured difference in pressure to the system controller. A valve 246 isdisposed in second T-fitting 242 to control connection of second testline section 212 b to differential pressure sensor 234.

A chemistry inlet line 252 is fluidly connected to first branch feederline 124. A valve 254 is disposed in chemistry feed line 252 to controlflow of fluid therethrough. A pressure sensor 256 is disposed withinchemistry inlet line 252 for providing signals to the system controllerindicative of the pressure of fluids therein. Chemistry inlet line 252splits into two sections 252 a, 252 b that both connect to achemistry-delivery system 400. Chemistry-delivery system 400, that willbe described in greater detail below, is comprised of a chemistryhousing 470 and a movable lid 520 that attaches to chemistry housing470. Chemistry housing 470 of chemistry-delivery system 400 includes twoseparate compartments or receptacles 482, 484. Compartment 482 isdimensioned to receive a container containing a chemical reagent.Compartment 484 is dimensioned to receive a container that containsbuilder material to react with the chemical reagent in the firstcontainer to create a microbial deactivation fluid. As shall bedescribed in greater detail below, lid 520 is designed to isolate therespective compartments when in a closed position.

Section 252 b of chemistry inlet line 252 communicates with thecontainer containing the builder material. Section 252 a of chemistryinlet line 252 connects to the container holding the chemical reagent. Avalve 258 is disposed within section 252 a of chemistry inlet line 252to control the flow of fluid therethrough.

Each compartment of chemistry housing 470 of chemistry-delivery system400 is designed to have an outlet port formed at the upper edge thereof.A chemistry outlet line 262 connects chemistry-delivery system 400 toreturn line 162. Chemistry outlet line 262 has a first overflow line 262a and a second overflow line 262 b. First overflow line 262 a connectsthe upper portion of the first compartment of the housing to outlet line262. Second overflow line 262 b connects the upper portion of the secondcompartment of the housing to outlet line 262. A chemistry housing drainline 264 connects the bottom of chemistry housing 470 to chemistryoutlet line 262. Chemistry housing drain line 264 has a first section264 a connected to the lowest part of the first compartment in chemistryhousing 470, and a second section 264 b is connected to the lowest partof the second compartment in chemistry housing 470. A valve 266 disposedwithin chemistry housing drain line 264 controls the flow of fluid fromchemistry-delivery system 400. A drain line 272 connects to chemistryoutlet line 262. A valve 274 is disposed in drain line 272 to controlthe flow of fluid therethrough. Downstream of drain line 272, a valve276 is disposed in chemistry outlet line 262.

As shown in FIG. 4, a portion 252 a of chemistry inlet line 252 isconnected to chemistry outlet line 262. In this respect, portion 252 aof chemistry inlet line 252 is disposed relative to two valves 254, 276such that chemistry inlet line 252 is always in communication withchemistry outlet line 262 and ultimately, in connection with return line162. In other words, a direct path is established between first branchfeeder line 124 and chemistry outlet line 262. A connecting line 282connects water inlet line 102 to chemistry inlet line 252. Twospaced-apart valves 284, 286 are disposed in connecting line 282. An airline 288 is connected to connecting line 282 between valves 284, 286. Adirection check valve 289 is disposed in air line 288 to permit air flowonly into connecting line 282.

Referring now to the drawer assembly shown in FIG. 4, an overflow line292 is connected to plate 642 so as to communicate with thedecontamination chamber. The other end of overflow line 292 is connectedto a drain source. A check valve 293 is disposed within overflow line292 to allow the flow of fluid out of the decontamination chamber, butto restrict the flow of any fluid into the decontamination chamberthrough overflow line 292. A sensor 294 is disposed within overflow line292 downstream from directional check valve 293, to indicate when fluidis flowing therethrough. A make-up air line 296 is also connected to thedecontamination chamber, as schematically illustrated in FIG. 3. Afilter element 297 is disposed within make-up air line 296 to filter anyair flowing into the decontamination chamber. In this respect, adirectional check valve 298 is disposed within make-up air line 296between filter element 297 and the decontamination chamber. Directionalcheck valve 298 allows the flow of air into the decontamination chamber,but restricts the flow of air or fluid out of the decontaminationchamber.

Filter Assembly 300

Referring now to FIG. 10, the filter assembly 300 is best seen. Filterassembly 300 is comprised of a support member 310 having a filtercartridge 340 attached thereto. Support member 310 has a central bore312 formed therein. An annular slot 314 is formed in support member 310around bore 316. Annular slot 314 is concentric to central bore 312 anddefines an annular wall 316 within support member 310. A first passage322 communicates with slot 314. A second passage 324 communicates withbore 312. Support member 310 is designed to be inserted into systemfeeder line 122 by conventional fasteners, such that first passage 322defines an inlet port and second passage 324 defines an outlet port. Adrain opening 326 extends from the bottom of support member 310 toannular slot 314. A drain conduit 328 is attached to drain opening 326.

Filter cartridge 340 includes a housing 342 and a base 344 that aredimensioned to contain an inner filter element 370. Base 344 iscomprised of a mounting plate 346 having two annular walls 352, 354 thatextend downward from the bottom of plate 346. The inner annular wall 352is dimensioned to be received within bore 312, formed in support member310. Outer annular wall 354 is dimensioned to engage the outer-mostinner surface of annular slot 314. O-rings 356 are provided on outersurfaces of inner and outer walls 352, 354 to form a seal with surfacesof central bore 312 and annular slot 314, as illustrated in FIG. 10. Anupper annular wall 362 extends from the upper surface of plate 346. Thefree end of wall 362 includes an outward-extending flange 364 thatdefines a planar upper surface 366. A central bore 368 extends throughbase 344, as illustrated in FIG. 10. Housing 342 is preferably attachedto base 344 by means of ultrasonic welding.

A filter element 370 is mounted onto surface 366 of filter base 344. Inthe embodiment shown, filter element 370 has three layers 372 a, 372 b,372 c of filter media. As will be appreciated by those skilled in theart, each layer 372 a, 372 b, 372 c filters a different size particle,with inner layer 372 a having the highest filtering capability. A cap374 is provided at the upper end of filter element 370. An outer annularchamber 376 is formed between the outer housing 342 and outer layer 372c of the filter media. A central cavity 378 is formed within filterelement 370. Cavity 378 communicates with bore 312 in support member310, which in turn communicates with feeder feed line 122. Filtercartridge 340 may be attached to support member 310 in a number ofdifferent ways. In the embodiment shown, a bayonet-type lock arrangementis shown.

Test line 212 b is attached to housing 342, and it communicates with theannular chamber 376 formed therein. Openings 348 are formed throughplate 346 of base 344 to permit the flow of fluid therethrough. Openings348 are positioned to allow annular chamber 376 to communicate with slot314, as shown in FIG. 10. As illustrated by arrows in FIG. 10, water ora decontamination fluid from system feed line 122 flows into firstpassage 322 (the inlet port) of support member 310 and upwards throughopening 348 in plate 346 into annular chamber 376. The water ordecontamination fluid then flows through filter element 370, where thewater or fluid is filtered as it passes through layers 372 a, 372 b, 372c of filter media. The water or fluid then flows down through cavity 378and central bore 312 in support member 310 and, ultimately, to secondpassage 324 (the outlet port) into fluid feed line 122.

Chemistry-Delivery System 400

Referring now to FIGS. 11-17, the chemistry-delivery system 400 is bestseen. Chemistry-delivery system 400 is designed to use achemistry-holding device 430. FIG. 11 shows a chemistry-storage package412 containing a chemistry-holding device 430. Chemistry-storage package412 is comprised of a molded base 414 having a peel-away lid or cover416. Base 414 is generally comprised of an integrally molded polymermaterial. Cover 416 is preferably a polymer film that is attached tobase 414, so as to be easily peeled away. A tab 418 extends from, and isintegrally formed as part of cover 416 to facilitate removal of cover416 from base 414. Chemistry-storage package 412 is dimensioned toloosely contain chemistry-holding device 430.

Referring now to FIG. 12, chemistry-holding device 430 is best seen.Chemistry-holding device 430 is basically comprised of two side-by-sidecontainers 432, 434 that are connected along their upper surfaces by abridge portion 436. Both containers 432, 434 are slightly conical inshape and include a tubular body 438 that is defined by an annular wall442. The lower end of each wall 442 includes an inwardly turned edge 444that defines an opening 446 at the bottom of each container 432, 434.The upper end of each container 432, 434 defines an opening 448. Theupper end of container 432, 434 includes an outward extending, steppedflange 452. Stepped flange 452 defines an annular, upward-facing surface452 a.

A filter element 456 is disposed at the bottom of each container 432,434. Filter element 456 is essentially a flat disk that is dimensionedto have an outer peripheral shape, matching the inner profile of eachcontainer 432, 434. In this respect, each filter element 456 isdimensioned to be snugly received in the bottom of container 432, 434,with the outer edge of filter element 456 resting on upward-facingsurface defined by inwardly extending edge 444.

A second filter element 458 is provided in container 432 to close theopened upper end thereof. Like filter element 456, filter element 458 isa flat disk that is dimensioned to have an outer peripheral shape,matching the inner profile of stepped flange 452 of wall 442. In thisrespect, in the embodiment shown, filter element 458 is circular inshape and is dimensioned to be snugly received within stepped-flange 452of container 432, with filter element 458 resting on annular surface 452a defined by stepped flange 452.

A thin polymer layer 462 is provided to close the opened upper end ofcontainer 434. Polymer layer 462 is dimensioned to rest upon annularsurface 452 a defined by stepped flange 452 of container 434. Filterelements 456, 458 and polymer layer 462 are preferably ultrasonicallywelded to containers 432, 434.

Filter elements 456, 458 are formed of a filter material that isimpermeable to the dry reagents to be contained within containers 432,434, but is permeable to water and to dissolved reagents. Filter element456 is preferably dimensioned to filter particles larger than 50 microns(μm) and, more preferably, to filter particles of about 10 microns (μm).Suitable filter materials include polypropylene, polyethylene, nylon,rayon, rigid porous media (such as POREX™), expanded plastic or otherporous plastic, fabric, felt, mesh, and analogous materials. Thefiltering capabilities of the selected filtering material are related tothe dry reagent contained within respective container 432, 434. In apreferred embodiment, filter element 456 is preferably formed of anethylene-based polymer, such as polypropylene or polyethylene. Container432 is dimensioned to contain a predetermined amount of acetylsalicylicacid, i.e., aspirin.

Container 434 is dimensioned to receive builder components that containa per-salt, preferably sodium perborate. The builder components aresupplied at sufficient amounts to react with the acetylsalicylic acid togenerate peracetic acid at a concentration of 1,500 ppm or better withthe volume of water to be used in the system in which chemistry-deliverysystem 400 is to be used. The sodium perborate generates hydrogenperoxide, which, in combination with acetylsalicylic acid as an acetyldonor, forms peracetic acid.

The use of powdered reagents that react in a common solvent to generatechlorine gas, hydrogen peroxide, hypochlorous acid, hypochlorides, orother strong oxidants which have biocidal effects is also contemplated.

Container 434 also preferably includes various chemistries, such asbuffers, inhibitors and wetting agents. Preferred copper and brasscorrosion inhibitors include azoles, benzoates, and other five-memberring compounds, benzotriazoles, tolytriazoles, mercaptobenzothiazole,and the like. Other anti-corrosion buffering compounds includephosphates, molybdates, chromates, dichromates, tungstates, vanadates,and other borates, and combinations thereof. These compounds areeffective for inhibiting steel and aluminum corrosion. For hard water inwhich calcium and magnesium salts may tend to precipitate, asequestering reagent, such as sodium hexametaphosphate, is alsoincluded.

As illustrated in FIG. 12, chemistry-storage package 412 is dimensionedto receive the chemistry-holding device 430, so as to allow storage andshipping of the chemistry-holding device 430 in a sealed package.

Referring now to FIGS. 13-17, chemistry-delivery system 400 is bestseen. Chemistry-delivery system 400 is comprised of an elongated, oblonghousing 470 having a lid 520 that is pivotally attached thereto. Anoutward extending collar 472 extends around the periphery of housing470. As best seen in FIGS. 13, and 14, an obround recess 474 is formedin the upper surface of housing 470. Housing 470 includes twospaced-apart, side-by-side compartments or receptacles 482, 484 that aredimensioned to receive, respectively, containers 432, 434 ofchemistry-holding device 430. Compartments 482, 484 extend from recess474 into housing 470. Compartments 482, 484 are generally cylindrical inshape and slightly larger than containers 432, 434 to define a space 488around the sides and bottoms of containers 432, 434, as best illustratedin FIG. 17.

Stepped regions 486, 488 are formed at the upper ends of compartments482, 484. Stepped regions 486, 488 are dimensioned to receive steppedflanges 452 on containers 432, 434 and are formed below the surface ofrecess 474, as best seen in FIG. 13. A slot 489 is formed in recess 474between compartments 482, 484. Slot 489 is dimensioned to receive bridgeportion 436 of chemistry-holding device 430.

A first inlet passage 492 is formed in collar 472 of housing 470. Inletpassage 492 extends from one end of housing 470 to an elongated opening494 defined on the upper surface of recess 474 of housing 470. A secondinlet passage 496 is formed into housing 470 and communicates with asecond oblong opening 498 on the surface of recess 474 of housing 470.First inlet passage 492 is connected to branch 252 a of chemistry-inletline 252 of fluid-circulation system 100. Second inlet passage 496 isconnected to branch 252 b of chemistry-inlet line 252. Overflow ports502, 504 are provided, respectively, at the upper portions ofcompartments 482, 484. Overflow port 502 in compartment 482 is connectedto overflow line 262 a of fluid-circulation system 100. Overflow port504 in compartment 484 is connected to overflow line 262 b offluid-circulation system 100. Drain openings 506, 508 are provided atthe bottom of compartments 482, 484, respectively. Opening 506 in thebottom of compartment 482 is connected to section 264 a ofchemistry-housing drain line 264. Opening 508 in the bottom ofcompartment 484 is connected to section 264 b of chemistry-housing drainline 264.

Lid 520 is basically an elongated plate having an outer peripheral shapecorresponding to the shape of collar 472 of housing 470. One end of lid520 includes two spaced-apart arms 522 that are dimensioned to straddlea support bracket 476 on the housing 470. A pin 524, extending throughspaced-apart arms 522 and support bracket 476, pivotally mounts lid 520to housing 470. Lid 520 includes an obround recess in the lower surfacethereof. Recess 532 has the same dimensions as recess 474 in housing470. A seal element 542 is disposed in recess 532 in lid 520. A flatmetallic plate 544 is molded within seal element 542, as best seen inFIGS. 13 and 17. Two spaced-apart, circular cavities 552, 554 are formedin seal element 542 to one side of plate 544. Cavities 552, 554 areformed between plate 544 and lid 520. A channel 556 extends fromcircular cavity 552 and communicates with an opening 558 that extendsthrough seal element 542. Opening 558 is disposed to be in registry withopening 494 in housing 470 when lid 520 is in a closed position, asshall be described in greater detail below. Similarly, a channel 562extends from circular cavity 554 and communicates with an opening 564that extends through seal element 520. Opening 564 is disposed to be inregistry with opening 498 in housing 470 when lid 520 is in a closedposition. Seal element 542 is preferably integrally formed of aresilient material. Circular openings 572, 574, in the underside of sealelement 542 expose plate 544. Openings 572, 574 are in registry withcircular cavities 552, 554 on the opposite side of plate 544. A circularpattern of slot-shaped apertures 576 are formed through plate 544, suchthat cavity 552 communicates with opening 572. A circular pattern ofcircular apertures 578 are formed through plate 544, such that cavity554 communicates with opening 574. Apertures 576, 578 are dimensioned todefine spray orifices for spraying fluid into compartments 482, 484 whenlid 520 is attached to housing 470. In this respect, openings 572, 574are disposed on lid 520 to align with compartments 482, 484,respectively, when lid 520 is in a closed position as shown in FIG. 17.Apertures 576 are dimensioned such that the total cross sectional areaof apertures 576 are between about 1% and about 10% of the total crosssectional area of apertures 578. In one embodiment, the total crosssectional areas of apertures 576 are between about 3% and about 7% ofthe total cross sectional area of apertures 578. In another embodiment,the total cross sectional are of apertures 576 are about 5% of the totalcross sectional area of apertures 578.

A blade element 582 is attached to plate 544 within opening 574. Bladeelement 582 is disposed to be in registry with compartment 484 inhousing 470. A tab 588 extends to one side of housing 470. Lid 520includes a latch assembly 590, including a latch handle 592 and a latchring 594 dimensioned to capture tab 588 and pull lid 520 into sealingengagement with housing 470. In this respect, lid 520 is movable betweena first open position, as illustrated in FIG. 13, and a second closedposition, as illustrated in FIG. 17. As shown in FIG. 17, blade element582 is dimensioned to penetrate plastic cover layer 462 on the secondcontainer 434.

Drawer Assembly 600

Referring now to FIGS. 18-23, drawer assembly 600 is best seen. Drawerassembly 600 includes two spaced-apart side panels 612. Each side panel612 has a drawer slide 614 associated therewith. Drawer slide 614 has afirst section 614 a attached to housing structure 22 and a secondsection 614 b attached to a side panel 612. Each side panel 612 has aninwardly extending flange 616 at the upper end thereof. Drawer tray 622is dimensioned to rest upon inward-extending flanges 616. Drawer tray622 is generally comprised of a flat panel having a recessed cavity 624formed therein. Cavity 624 has a pre-determined contour dimensioned toreceive instrument container 800. As illustrated in FIG. 18, a ledge 626is formed about the peripheral edge of cavity 624 to receive instrumentcontainer 800. Drawer tray 622 is positioned on inwardly extendingflanges 616 of side panels 612 by cylindrical posts 628. Drawer tray 622has a generally planar surface 632, best seen in FIG. 2, that surroundscavity 624. A front door panel 634, best seen in FIGS. 1 and 2, isattached to side panels 612. A control button 636, for controllingmovement of drawer assembly 600, is mounted to front panel 634.

A drawer sealing assembly 640 is disposed above drawer tray 622. Drawersealing assembly 640 includes a plate 642 that is disposed above drawertray 622. The dimensions of plate 642 generally correspond to thedimensions of drawer tray 622. A static seal 644 is disposed on thelower surface of plate 642. Static seal 644 is disposed about theperiphery of cavity 624 in drawer tray 622, so as to engage flat uppersurface 632 of drawer tray 622. It is contemplated that the bottomsurface of plate 642 can be generally hemispherical in shape within theboundary defined by static seal 644. In this respect, the highest pointof the hemispherical portion of the bottom side of plate 642 is higherthan any point at which static seal 644 contacts plate 642. Aninflatable bladder 646 is disposed between plate 642 and housingstructure 22, as illustrated in FIG. 18. An air line 648 is connected tobladder 646 to inflate and deflate the same. When inflated, air bladder646 is operable to force plate 642 downward toward drawer tray 622,wherein static seal 644 engages upper surface 632 of drawer tray 622 toform a seal about cavity 624 formed therein. When plate 642 is sealedagainst surface 632 of drawer tray 622, cavity 624 within drawer tray622 defines a sealed decontamination chamber. A plurality of springs 647are connected at one end to the upper side of plate 642 and at the otherend to housing structure 22. Springs 647 are tension springs that biasplate 642 and static seal 644 away from the planar portion of drawertray 622.

Overflow line 292 and make-up air line 296 are attached to plate 642 andextend therethrough. In an alternative embodiment of seal plate 642 asdescribed above, where the bottom side of seal plate 642 ishemispherical in shape, overflow line 292 is located at the highestpoint of the hemispherical portion of the bottom side of seal plate 642.In this respect, when plate 642 is in a sealing position against drawertray 622, overflow line 292 and make-up air line 296 are incommunication with the decontamination chamber defined between plate 642and drawer tray 622. Section 124 a of first branch feeder line 124 isalso attached to plate 642, as illustrated in FIG. 18. Section 124 a offirst branch feeder line 124 connects to a spray nozzle 652 disposed onthe bottom side of plate 642.

A drawer drive assembly 650 is provided to move drawer tray 622 betweena closed position shown in FIG. 1 and an open position shown in FIG. 2.Drive assembly 650 is comprised of a drive motor 652 connected tohousing structure 22. In a preferred embodiment, drive motor 652 is anelectric motor. A pinion gear 656 is attached to output shaft 654 ofdrive motor 652. Pinion gear 656 engages a rack 658 on side panel 612 ofdrawer assembly 600. As best seen in FIGS. 2 and 3, drawer slides 614and rack 658 on side panel 612 of drawer assembly 600 are disposed so asto move drawer tray 622 at an angle relative to horizontal. In theembodiment shown, drawer tray 622 moves within a plane that isapproximately 20° down from horizontal.

Connector assembly 660 is provided to allow the lines from fluidcirculation system 100 to be connected to, and disconnected from, drawerassembly 600, so as to allow the opening and closing of drawer tray 622.Connector assembly 660 is comprised of a manifold section 670, that ismountable to drawer tray 622 and is movable therewith, and a platensection 730, that is movable into and out of engagement with manifoldsection 670. Manifold section 670 is attached to the bottom of drawertray 622 and has a plurality of male connectors 672A, 672B, 672Cextending to one side thereof. The platen section 730 includes aplurality of female connectors 732A, 732B, 732C extending therefrom.Female connectors 732A, 732B, 732C are dimensioned to mate with maleconnectors 672A, 672B, 672C. Platen section 730 is operable to connectwith and to disconnect from manifold section 670 when drawer assembly600 is in a closed position, so as to connect drawer tray 622 to fluidcirculation system 100.

Referring now to FIGS. 19, 20, and 23, manifold section 670 is bestseen. Manifold section 670 is comprised of a block 674 having a flatsurface 674 a dimensioned to engage the under side of drawer tray 622.Three bored openings extend into block 674 from flat surface 674 a.Bored openings define cylindrical cavities 682A, 682B, 682C as best seenin FIG. 23 that shows cavity 682A. An annular groove 684 is formed inthe inner surface of each cylindrical cavity 682A, 682B, 682C near thelower end thereof. A cylindrical aperture 686 axially aligned with eachcylindrical cavity 682A, 682B, 682C and extends through the bottom ofblock 674. Aperture 686 has a smaller diameter than cylindrical cavity682A, as illustrated in FIG. 23.

Each cylindrical cavity 682A, 682B, 682C is dimensioned to receive aninsert 692A, 692B, 692C, respectively. In the embodiment shown, insert692A, best seen in FIG. 23, is a drain insert and is disposed withincylindrical cavity 682A. Inserts 692B, 692C, best seen in FIG. 20, areconnector inserts and are disposed in cylindrical cavities 682B, 682C,respectively. Each insert 692A, 692B, 692C is a tubular structure havinga closed lower end and an opened upper end. An annular flange 694extends outwardly from the upper end each insert 692A, 692B, 692C, asillustrated in FIG. 20. A threaded rod 696 extends from the bottom ofeach insert 692A, 692B, 692C. Rod 696 is dimensioned to extend throughaperture 686 in the bottom of manifold block 674. A plurality ofopenings 698 is formed in the sidewall of the inserts 692A, 692B, 692C.

As shown in FIG. 23, each insert 692A, 692B, 692C is dimensioned to bedisposed within its respective cylindrical cavity 682A, 682B, 682C inmanifold block 674 with flange 694 disposed on the upper, inner surfaceof drawer tray 622. Conventional fastener nuts 702 on threaded rods 696are tightened to draw inserts 692A, 692B, 692C down into manifold block674 and force upper, planar surface of manifold block 674 intoengagement with the lower, outer surface of drawer tray 622, therebycapturing drawer tray 622 between flanges 694 and block 674. A pluralityof o-rings 704 is disposed between inserts 692A, 692B, 692C and drawertray 622 and manifold block 674 to form a fluid-tight seal between theinserts 692A, 692B, 692C and drawer tray 622 and manifold block 674. Asillustrated in FIG. 23, apertures 698 in inserts 692A, 692B, 692C aredisposed to be in communication with annular grooves 684 formed withinsurface of cylindrical cavities 682A, 682B, 682C in manifold block 674.

In FIG. 23, drain insert 692A is shown. Connector inserts 692B, 692C,shown in FIG. 20, are similar in all respects with the exception thatconnector inserts 692B, 692C include an upwardly extending annularcollar 706 that defines female inlet fittings, as shall be described ingreater detail below.

As mentioned above, male connectors 672A, 672B, 672C extend to one sideof block 674. Each connector 672A, 672B, 672C is essentially identicaland, therefore, only one shall be described in detail. Male connector672A, best seen in FIG. 23, is comprised of a cylindrical body 712having an inner passage 714 extending therethrough. Body 712 is orientedsuch that passage 714 is aligned and communicates with annular groove684 in cylindrical cavity 682A. Similarly, passage 714 in body 712 ofmale connector 672B communicates with annular groove 684 in cylindricalcavity 682B, and passage 714 in body 712 of male connector 672Ccommunicates with annular groove 684 in cylindrical cavity 682C. Anannular channel 716 is formed in outer surface of each body 712 toreceive o-ring 718, as best illustrated in FIG. 23.

Manifold section 670 and inserts 692A, 692B, 692C may be formed of ametal or polymer material. In a preferred embodiment, manifold section670 is formed of a high-strength polymer material. Inserts 692A, 692B,692C are formed of a metal such as, by way of example and notlimitation, stainless steel.

As best seen in FIG. 20, a plurality of distribution lines 124 b areconnected to manifold block 674 and communicate with annular groove 684associated with cylindrical cavity 682C. Distribution lines 124 b areconnected to a plurality of spray nozzles 722 disposed on the upper,inner surface of drawer tray 622, as best seen in FIG. 18.

As indicated above, cavity 624 in drawer tray 622 has a pre-determinedconfiguration. Because drawer tray 622 is oriented at an angle, manifoldblock 674 is oriented such that drain insert 692A is disposed at thelowest-most portion of drawer tray 622, as schematically illustrated inFIG. 4.

Manifold block 674 includes spaced-apart locating openings 724, bestseen in FIG. 20. Locating openings 724 have counter-sunk leading edges724 a, best illustrated in FIG. 19.

Referring now to FIGS. 19, 21, and 22, platen section 730 of connectorassembly 660 is best seen. Platen section 730 includes an actuator 734connected to housing structure 22 for reciprocally moving femaleconnectors 732A, 732B, 732C into and out of engagement with maleconnectors 672A, 672B, 672C, respectively, on manifold section 670. Inthe embodiment shown, actuator 734 is a pneumatic cylinder having a rod736 extending therefrom. The free end of rod 736 is threaded to receivea support bar 738. In the embodiment shown, support bar 738 is generallyrectangular in shape and has a flat mounting surface 738 a on one sidethereof. A larger rectangular plate 742 is mounted to support bar 738.In the embodiment shown, spaced-apart, elongated fasteners 744 extendthrough apertures 746 in plate 742 into support bar 738 to mount plate742 to support bar 738. As best seen in FIGS. 21 and 22, plate 742 issignificantly larger than support bar 738. Plate 742 is mounted tosupport bar 738, along one side of plate 742. As best seen in FIG. 22,apertures 746 within plate 742 are significantly larger than thediameter of fasteners 744. In the embodiment shown, fasteners 744 areelongated cap screws. A washer 748 is disposed over enlarged apertures746. A biasing spring 749 is disposed between the head of each cap screwfasteners 744 and washer 748.

Recesses 752 are formed at the corners of support bar 738 and definecavities between support bar 738 and mounting plate 742, as best seen inFIG. 23. Within each recess 752, a pin 754 is mounted to support bar738. Each pin 754 on support bar 738 has an associated pin 756 mountedon plate 742, as best seen in FIG. 22. Tension springs 758 are attachedto the associated pins 754, 756. In this respect, plate 742 is movablerelative to support bar 738 in all three directions. Specifically, plate742 may slide across surface 738 a of support bar 738 within the limitsallowed by the dimensions of aperture 748 in plate 742 that surroundsfasteners 744. Tension springs 758 mounted to pins 754, 756 on supportbar 738 and plate 742 act as a means for centering plate 742 relative tosupport bar 738. Similarly, because plate 742 is mounted to support bar738 along one side of plate 742, plate 742 may rotate slightly relativeto support bar 738 if sufficient force is applied to the end of plate742. As illustrated in FIGS. 21 and 22, support bar 738 and plate 742are disposed at an angle to accommodate the orientation of drawer tray622.

Female connectors 732A, 732B, 732C are mounted to the free end of plate742. Each connector 732A, 732B, 732C has a base portion 762 having athreaded nipple 762 a that extends through a hole in plate 742. Athreaded collar 764 attaches to nipple 762 a to secure base section 762of each connector 732A, 732B, 732C to plate 742. Female connectors 732A,732B, 732C are spaced apart to be in registry with male connectors 672A,672B, 672C, respectively, on manifold section 670. In this respect,actuator 734 is disposed relative to housing structure 22 and relativeto manifold block 674, such that reciprocal movement of actuator rod 736engages or disengages female connectors 732A, 732B, 732C on platensection 730 to male connectors 672A, 672B, 672C on manifold section 670.Base sections 762 of female connectors 732A, 732B, 732C are preferablyattached to flexible tubing 766 to allow movement of platen section 730.Female connector 732A is attached to return line 162. Female connector732B is connected to second branch feeder line 126 of fluid circulationsystem 100. Female connector 732C is connected to first branch feederline 124 of fluid circulation system 100.

To assist in aligning female connectors 732A, 732B, 732C on platensection 730 with the male connectors 672A, 672B, 672C on manifoldsection 670, aligning pins 772 extend from plate 742, as best seen inFIG. 19. Aligning pins 772 are parallel to each other and includerounded leading ends 772 a. Pins 772 are disposed to be in alignmentwith locating openings 724 in manifold block 674. As illustrated in FIG.19, the positioning of aligning pins 772 into locating openings 724 inmanifold block 674 ensures that female connectors 732A, 732B, 732C onplaten section 730 align with the male connectors 672A, 672B, 672C onmanifold section 670.

The ability of plate 742 to float, i.e., move to a limited extent in allthree directions on support bar 738, helps facilitate proper alignmentand engagement between the female connectors 732A, 732B, 732C on movableplaten section 730 and male connectors 672A, 672B, 672C on manifoldsection 670 that is stationary when the drawer tray 622 is in the closedposition

Container 800 has a shape wherein container 800 can be received incavity 624 in drawer tray 622 in one orientation, as illustrated in FIG.24.

Instrument Container 800

Referring now to FIGS. 24-27, instrument container 800 is best seen.Instrument container 800 is generally comprised of tray 812 and lid 912that is attachable to tray 812. Tray 812 is generally cup-shaped and hasa bottom wall 814 and a continuous side wall 816 that extends about theperiphery of bottom wall 814 to one side thereof. Bottom wall 814 andside wall 816 define a cavity 818 in which medical instruments or otheritems to be deactivated are to be inserted.

The upper edge of side wall 816 is shaped to define a channel 822, bestseen in FIG. 27. Channel 822 extends continuously about the upper edgeof side wall 816. Channel 822 is dimensioned to receive a continuous,flexible seal 824. In the embodiment shown, seal 824 is an inflatableseal. An air conduit 826, schematically illustrated in FIG. 4,communicates with seal 824 by means of a fitting (not shown) that ismounted to instrument container 800.

Bottom wall 814 is formed to have a contoured upper surface 832. Bottomwall 814 includes a centrally located mounting pad 834 that issurrounded by a trough 836. Mounting pad 834 is generally rectangular inshape and includes a number of upwardly extending, spaced-apart pins orposts 838. Pins or posts 838 are provided to receive and support (shownin phantom in FIG. 24) medical instruments 842 or items to bemicrobially decontaminated. Mounting pad 834 has a recess or relief 844formed therein. Recess or relief 844 is formed along the edge ofmounting pad 834 and has an upper surface that is disposed above trough836. Connection fittings 846 are disposed within recess or relief 844.Two directional spray nozzles 852 are mounted onto mounting pad 834.Spray nozzles 852 are dimensioned to generate fan-like spray patternsthat are directed to the longitudinal ends of tray 812. Spray nozzles852 are disposed in shallow fan-like recesses 854 formed in the mountingpad 834.

A drain fluid assembly 862 is formed in bottom wall 814 of tray 812 toallow a microbial deactivation fluid to flow out of instrument container800. Drain fluid assembly 862 is disposed within trough portion 836adjacent to side wall 816 and shall be dimensioned as described below.

In the embodiment shown, two inlet fluid assemblies 866, 868 are formedin tray 812 to allow a microbial deactivation fluid to flow intoinstrument container 800. Fluid inlet assembly 866 facilitates flow of amicrobial deactivation fluid into tray 812 through spray nozzles 852.Fluid inlet assembly 866 communicates with a V-shaped, internal cavity872, formed within bottom wall 814 of tray 812, as illustrated by dashedlines in FIG. 24. Cavity 872 communicates with spray nozzles 852. Fluidinlet assembly 868 facilitates fluid flow to connection fittings 846within relief or recess 844 in mounting pad 834. Connection fittings 846are connectable to certain medical devices and instruments by flexibleconnectors 848 (depicted by phantom lines in FIG. 24) to direct amicrobial deactivation fluid through lumens or passages withininstruments 842. Fluid inlet assembly 868 communicates with a generallytriangular-shaped cavity 874 formed within bottom wall 814 of tray 812.Cavity 874 communicates with connecting fitting 846.

Fluid inlet assemblies 866, 868 and drain fluid assembly 862 areessentially identical and, therefore, only fluid inlet assembly 866shall be described in detail. Another embodiment of fluid inlet assembly866 is shown in FIG. 25. Fluid inlet assembly 866 is disposed within acylindrical boss 882 that is formed on the underside of bottom wall 814of tray 812. An opening 884 of varying diameter extends into boss 882and communicates with v-shaped cavity 872. A sleeve 886 having anoutward-extending flange 886 a is disposed within opening 884, such thatsleeve 886 extends downward, out from boss 882. Sleeve 886 defines aninner cylindrical passage 887. A retaining ring 888 within a slot inboss 882 secures sleeve 886 in boss 882. An o-ring 889 is disposedbetween flange 886 a of sleeve 886 and boss 882 to form a fluid-tightseal therebetween.

Opening 884 has a section 884 a dimensioned to receive outward extendingflange 886 a. In this respect, flange 886 a of sleeve 886 is retainedwithin opening 884 by a retaining ring 888. Section 884 a of opening 884and flange 886 a of sleeve 886 are dimensioned such that flange 886 a isretained wherein sleeve 886 can move, i.e. float, from side to side. Theextent of lateral, or side to side movement of sleeve 886 is limited bycontact between the edge of extending flange 886 a and surface 884 a ofopening 884.

Sleeve 886 has an outer diameter dimensioned to be received withincollar 706 of connector insert 692C on drawer tray 622. An o-ring 892 isdisposed in the outer surface of sleeve 886 to form a fluid-tightconnection therewith. It can be appreciated that the floating movementof sleeve 886 within opening 884 provides for alignment of sleeve 886with collar 706.

A valve element 894 is disposed within passage 887 in sleeve 886. Valveelement 894 is tubular in shape and has an opening 896 extending axiallytherethrough. A barrier 898 is disposed within opening 896. Barrier 898is comprised of a filter material that is gas and vapor permeable, i.e.,is capable of allowing moisture and gas to pass therethrough butprevents liquid, bacteria, and/or organisms from passing therethrough. Afirst set of spaced-apart apertures 902 are formed in the side of valveelement 894 to one side of barrier 898. A second set of spaced-apartapertures 904 are formed in the side of valve element 894 to the otherside of barrier 898. O-rings 906 are provided on the external surface ofvalve element 894 to form a fluid-tight seal with the inner surface ofsleeve 886.

Valve element 894 is movable between an open position, shown in FIG. 25,and a closed position, shown in FIG. 26. In the open position, fluid mayflow around barrier 898 into instrument container 800, as depicted bythe arrows in FIG. 25. In the closed position, valve element 894 ismoved up into sleeve 886, wherein apertures 902 are within sleeve 886and barrier 898 prevents liquids, bacteria, and/or organisms frompassing into container 800.

Valve element 894 is in an open position during a decontamination cycle.Following a decontamination cycle and before container 800 can beremoved from drawer tray 622, an actuator 908, schematically illustratedas a pin in FIGS. 25 and 26, moves valve element 894 from an openposition to a closed position.

Referring now to FIGS. 29A through 29D, a fluid inlet assembly 1200illustrating another embodiment of the present invention is shown. Fluidinlet assembly 1200 is basically comprised of container connectorassembly 1210 and a valve element 1240. Fluid inlet assembly 1200 isdimensioned to operatively mate with a tray post 1310. Containerconnector assembly 1210 is comprised of a cylindrical boss 1212 and asleeve 1214. In the embodiment shown, cylindrical boss 1212 is formed onthe underside of bottom wall 814 of tray 812. Cylindrical boss 1212 hasan inner surface 1216 of various diameters that define an opening 1218extending through cylindrical boss 1212. Opening 1218 is in fluidcommunication with v-shaped cavity 872. Surface 1216 includes adownward-facing annular surface 1216 a. Surface 1216 defines annularslot 1223 adjacent, i.e. below, annular surface 1216 a.

Sleeve 1214 is cylindrical in shape and has an outward extending flange1224 formed at one end of sleeve 1214. A grove is formed in the uppersurface of outward extending flange 1224. The grove is dimensioned toaccept an o-ring 1234. O-ring 1234 extends around the upper opening insleeve 1214, as shown in FIG. 29A. Sleeve 1214 defines an innercylindrical passage 1228. Formed in the inner wall of sleeve 1214 is alocking grove 1238.

As shown in FIG. 29A, sleeve 1214 is dimensioned to be disposed withinopening 1218 of cylindrical boss 1212. A retaining ring 1226 and outwardextending flange 1224 are dimensioned to be located in annular slot1223. Retaining ring 1226 and outward extending flange 1224 aredimensioned such that o-ring 1234 on outward extending flange 1224creates a fluid-tight seal with downward-facing annular surface 1216 aof cylindrical boss 1212. The outer diameter of outward extending flange1224 is smaller than the diameter of annular slot 1223 such that sleeve1214 can move, i.e. float, from side to side. The later movement ofsleeve 1214 is limited by contact with annular slot 1223. Cylindricalpassage 1228 of sleeve 1214 provides fluid communication with opening1218 of cylindrical boss 1212.

Valve element 1240 is composed of an upper housing 1242 and a lowerhousing 1262. Upper housing 1242 and lower housing 1262 are dimensionedto be joined together to define an inner cavity 1254. Upper housing 1242has a tubular section 1242 a and a flange section 1242 b extending fromthe bottom of tubular section 1242 a. A locking tab 1248 is located onthe outer surface of tubular section 1242 a. The outer surface oftubular section 1242 a has an annular grove located above locking tab1248. The grove is dimensioned to accept an o-ring 1246 that extendsaround tubular section 1242 a as shown in FIG. 29B. A series of tabs1252 are located on the bottom side of flange section 1242 b. Tabs 1252extend downward from flange section 1242 b and are located around theopening through upper housing 1242. An annular shoulder 1244 is definedalong the bottom surface of flange section 1242 b. Shoulder 1244 extendsaround the outer perimeter of flange section 1242 b.

Lower housing 1262 is tubular in shape with a cylindrical upper portion1262 a and a conical lower section 1262 b that tapers down to acylindrical collar portion 1262 c. Lower housing 1262 defines a cavity.The cavity includes a bored opening 1266 formed in cylindrical upperportion 1262 a. An annular seat 1266 a is defined in the lower end ofthe bored opening 1266. An annular grove is formed in the bored opening1266 above the annular seat 1266 a. The grove is dimensioned to acceptan o-ring 1274. The inner surface of conical lower section 1262 b isformed to define a conical surface that leads into bored opening 1266.

Shoulder 1244 in upper housing 1242 is dimensioned to receive the upperedge of cylindrical upper portion 1262 a of lower housing 1262. Upperhousing 1242 and lower housing 1262 are preferable formed from a plasticmaterial, and permanently attached to each other using sonic welding,spin welding or an adhesive. Upper housing 1242 and lower housing 1262define an inner cavity 1254. A filter element 1280 and a spring element1302 are disposed in cavity 1254.

Referring now to FIGS. 29C and 29D, filter element 1280 is best seen.Filter element 1280 is comprised of an upper filter support 1282, alower filter support 1284 and a filter membrane 1286. Upper filtersupport 1282 is comprised of a plurality of equally spaced-apart,outwardly-extending rib sections 1282 a that are connected at one end.Each rib section 1282 a has a tab 1282 b located on the upper surface ofeach rib section 1282 a.

Lower filter support 1284 is comprised of a plurality of radiallyextending rib sections 1284 a that are joined together at one end andconnected to a ring 1294 at another end. Rib sections 1282 a in upperfilter support 1282 are dimensioned to overlay rib sections 1284 a inlower filter support 1284 to exposed a filter membrane 1286, as bestseen in FIG. 29C.

Filter membrane 1286 is comprised of a filter material that is permeableto gas and vapor, i.e., is capable of allowing moisture and gas to passtherethrough but impermeable to liquid, bacteria, and/or organisms frompassing therethrough. Suitable filter medium material includes by way ofexample and not limitation, PVDF, or PTFE (polytetraflouroethylene).Filter membrane 1286 is generally circular in shape and is dimensionedto be located between upper filter support 1282 and lower filter support1284.

Upper filter support 1282, lower filter support 1284 and filter membrane1286 are attached to each other in a manner to capture filter membrane1286 between upper filter support 1282 and lower filter support 1284.Upper filter support 1282, lower filter support 1284 and filter membrane1286 may be attached using sonic welding or adhesive to create a filterelement 1280.

Filter element 1280 is dimensioned to be disposed within cavity 1254.Filter element 1280 is further dimensioned to be accepted into boredopening 1266 and rest on annular seat 1266 a. Ring 1294 of filterelement 1280 is dimensioned to sealingly engage o-ring 1274 to form afluid tight seal between filter element 1280 and lower valve housing1262, as shown in FIG. 29B.

Spring element 1302 is located above filter element 1280 to bias filterelement 1280 to a first position as shown in FIG. 29B. The innerdiameter of spring element 1302 is dimensioned to fit around tabs 1252in upper housing 1242 and tabs 1282 b on filter element 1280.

As shown in FIG. 29B, valve element 1240 is dimensioned to be receivedinto sleeve 1214. In this respect, the outer diameter of tubular section1242 a, o-ring 1246 and inner diameter of sleeve 1214 are dimensioned tocreate a fluid-tight seal between sleeve 1214 and valve element 1240.Valve element 1240 may be secured to sleeve 1214 in a twist-lock orthreaded fashion to engage locking tab 1248 of valve element 1240 intolocking grove 1238 of sleeve 1214.

Tray post 1310 is generally tubular in shape with one closed end 1316and a flange 1322 extending from the side wall of post 1310. The innerwall of post 1310 defines an inner cavity 1324. Located below closed end1316 is a series of apertures 1312 that allow fluid communication toinner cavity 1324. Located below apertures 1312 is a grove that isdimensioned to accept an o-ring 1314 that extends around the tubularportion of tray post 1310. The diameter of the portion of post 1310below flange 1322 is dimensioned to be accepted into drawer tray 622.

As shown in FIG. 29A, tray post 1310 is dimensioned to be accepted intothe cylindrical collar portion 1262 c of valve element 1240 whencontainer 800 is placed into drawer tray 622. O-ring 1314 creates afluid tight first seal between tray post 1310 and valve element 1240when tray post 1310 is received into cylindrical collar portion 1262 cof valve element 1240. As container 800 is being placed into drawer tray622, tray post 1310 engages valve element 1240. Engagement of tray post1310 with valve element 1240 causes tray post 1310 to contact lowerfilter support 1284 to move filter element 1280 to a second position,best seen in FIG. 29A. In this second position, cavity 1324 in tray post1310, cavity 1254 in valve element 1240 and opening 1218 in cylindricalboss 1212 are all in fluid communication. When filter element 1280 is inthe second position, fluid can flow around filter element 1280 as shownby the arrows in FIG. 29A.

Filter element 1280 is in a second position, as shown in FIG. 29A,during a decontamination cycle. Following a decontamination cyclecontainer 800 is removed from drawer tray 622. As container 800 isremoved from tray 622, tray post 1310 is also withdrawn from valveelement 1240. As tray post 1310 is being removed from valve element1240, spring element 1302 forces filter element 1280 down into boredopening 1266. Before tray post 1310 is completely withdrawn from valveelement 1240, filter element 1280 sealing engages o-ring 1274 to createa fluid-tight seal between filter element 1280 and lower valve housing1262. Valve element 1240 is designed such that the seal between filterelement 1280 and lower valve housing 1262 is reestablished before theseal between tray post 1310 and valve element 1240 is broken. As traypost 1310 continues to be withdrawn from valve element 1240, the sealbetween tray post 1310 and valve element 1240 is broken. In thisrespect, valve element 1240 is designed to create a microbial barrierbetween the medical instruments and devices in container 800 and theenvironment before container 800 is completely removed from drawer tray622; thereby keeping the medical instruments and devices in container800 in a microbially deactivated state.

Referring now to FIGS. 24 and 27, lid 912 is best seen. Lid 912 isgenerally a flat, planar element that is shaped to cover and enclose theopened, upper end of tray 812. Lid 912 includes a downward-extendingflange 914 that extends about the periphery of lid 912 and isdimensioned to capture the upper edge of side wall 816, as shown in FIG.27.

A locking device 922 is provided to secure lid 912 to tray 812. In theembodiment shown, locking device 922 is an elongated, channel-likeelement that is pinned at one end to tray 812. The channel defined inthe locking device 922 is dimensioned to capture the upper edge of tray812 and lid 912, as shown in FIG. 27.

Storage Cabinet 1000

Referring now to FIG. 28, a storage cabinet 1000 for storing previouslysterilized instrument containers 800 is shown. Storage cabinet 1000 isgenerally rectangular in shape and includes an upper section 1012 havinga plurality of storage compartments 1014 and a lower enclosed section1016. Upper section 1012 includes a plurality of horizontal shelves 1022and a central vertical divider 1024 that divides shelves 1022 intoside-by-side compartments 1014. Compartments 1014 are dimensioned toreceive instrument storage containers 800. Each shelf 1022 includesthree female connectors 1026A, 1026B, 1026C that are dimensioned to matewith connectors (not shown) on the bottom of tray 812 of instrumentcontainer 800. In this respect, female connectors 1026A, 1026B, 1026Care generally similar to the connectors in drawer tray 622 of drawerassembly 600. Drain opening 862 and sleeves 886 of fluid inletassemblies 866, 868 on the bottom of instrument container 800 align andmate with female connectors 1026A, 1026B, 1026C on cabinet shelves 1022.With respect to an alternative embodiment of the invention, valveelements 1240 are located on the bottom of instrument container 800. Inthis embodiment, connectors 1026A, 1026B and 1026C are similar to trayposts 1310 and are dimensioned to mate to valve elements 1240 (notshown) on the bottom of tray 812 of instrument container 800.

A blower 1032 is provided in the enclosed lower section 1016 of storagecabinet 1000. The outlet end of blower 1032 is connected to femaleconnectors 1026B, 1026C on shelves 1022 of storage cabinet 1000 byinternal ducts and conduits (not shown). A filter 1034 is disposeddownstream of blower 1032 to filter the air being blown to the ducts tofemale connectors 1026B, 1026C. A heater 1036 is provided downstream offilter 1034 to heat the air blown to instrument container 800. Femaleconnectors 1026B, 1026C connect to the inlet ports of container 800.Connector 1026A on shelves 1022 connects to the drain port of instrumentcontainer 800. Storage cabinet 1000 is operable to blow filtered, warmair through instrument containers 800 and through the instrumentscontained therein to dry the medical instruments and the interior ofcontainer 800 following a decontamination cycle.

Control means (not shown) can selectively direct the dry filtered air tospecific containers 800 within storage cabinet 1000. Barrier elements898 in fluid inlet assemblies 866, 868 and drain fluid assembly 862, asheretofore described, in instrument container 800 allow moisture and airto flow in and out of containers 800 but prevent organisms and bacteriafrom entering container 800.

Storage cabinet 1000 thus provides a method of storing medicalinstruments in a decontaminated state, awaiting further use.

Operation of System

Apparatus 10 shall now further be described with reference to theoperation thereof. One or more items to be deactivated, such as medical,dental, pharmaceutical, veterinary or mortuary instruments or thedevices, are loaded into the instrument container 800. Instrumentcontainer 800 can accommodate numerous types of medical instruments anditems. Certain medical instruments, such as bronchoscopes andendoscopes, have lumens, i.e., passages, extending therethrough.Flexible connectors 848 (not shown in detail) are used to connect fluidpassages 874 in tray 812 to the internal lumens of the medicalinstruments. More specifically, flexible connectors 848 are dimensionedto attach to connection fittings 846 within tray 812 and to attach tothe fittings on the medical instruments, so as to enable microbialdeactivation fluid to be forced through the lumens of the medicalinstruments. Once flexible connectors 848 have been attached to tray 812and the medical instrument, lid 912 is placed over tray 812 and islocked into position, using latch element 922 on tray 812.

With the instruments or items to be microbially decontaminatedpositioned within instrument container 800, an operator opens drawerassembly 600 of apparatus 10 to allow instrument container 800 to beplaced within drawer tray 622.

A decontamination cycle for apparatus 10 includes a number of specificphases that shall now be described.

Preparation Phase

During a user-preparation phase, drawer assembly 600 of apparatus 10 ismovable between a closed position shown in FIG. 1 and an open positionshown in FIG. 2 by manual manipulation of control button 636 on frontpanel 634. A valve element 894 is place into each connector inserts692C, 692B, 692C, as shown in FIG. 25, if the devices to bedecontaminated will be stored at the end of the decontamination cycle.Similarly, in an alternate embodiment, valve element 1240 is secured tosleeve 1214 by engaging locking tab 1248 on valve element 1240 intolocking grove 1238 in sleeve 1214 for each container connector assembly1210 on container 800. In preparation for a decontamination cycle,instrument container 800 with the instruments or items to be deactivatedis placed within drawer tray 622 in drawer assembly 600. As illustratedin the drawings, cavity 624 in tray 622 and the shape of instrumentcontainer 800 are such that instrument container 800 may be placedwithin cavity 624 in only one orientation. This ensures that drain fluidassembly 862 and fluid inlet assemblies 866, 868 on instrument container800 align with the corresponding drain and connector inserts 692A, 692B,692C within drawer tray 622.

With instrument container 800 placed within drawer tray 622, drawerassembly 600 is moved to a closed position, using drawer control button636.

During this user-preparation phase, a chemistry-holding device 430 isinserted within the chemistry-delivery system 400. To this end, accesspanel 22 a on housing structure 22 is moved to an open position toexpose lid 520 of chemistry-delivery system 400. Lid 520 is unlatchedand opened to expose compartments 482, 484 in chemistry-delivery system400. Chemistry-holding device 430 is removed from package 412 by peelingaway cover 416 of chemistry-storage package 412. Chemistry-holdingdevice 430 is inserted within housing 470 with polymer layer 462 overcompartment 484 beneath blade 582 on lid 520. Lid 520 is closed andlatched, as illustrated in FIG. 17. In this position, blade 582 on lid520 punctures polymer layer 462 covering compartment 484.

System-Sealing Phase

With instrument container 800 within drawer tray 622 of drawer assembly600 and drawer assembly 600 in a closed position, a decontaminationcycle may be initiated. A first phase of the decontamination cycle is asystem-sealing phase, wherein air is applied to inflatable bladder 646above plate 642. Inflating bladder 646 forces static seal 644 on plate642 down into engagement with the planar surface of drawer tray 622,thereby forming a complete seal around cavity 624 in drawer tray 622,and forming a sealed, decontamination chamber containing instrumentcontainer 800. Inflating bladder 646 is maintained throughout thedecontamination cycle.

Fill Phase

With bladder 646 sealing instrument container 800 within thedecontamination chamber, a fill phase is initiated. Valves 147, 168,198, 274 and 327 in drain lines 146, 166, 196, 272 and 328,respectively, are in a closed position. Also closed are valves 164, 236,246, 284, 286 and valves 254, 276 to the chemistry-delivery system 400.Valve 125 is in a first position as described above. The remainingvalves throughout apparatus 10 are opened to allow water from inlet line102 to enter system feed line 122 and flow throughout fluid circulationsystem 100. Incoming water is first filtered by filter elements 106, 108that remove macro particles above a certain size, such as 0.1 micron orabove. Filter elements 106, 108 are sized to successively filter outsmaller-sized particles. Incoming water is then treated by UV treatmentdevice 114 that applies ultra-violet (UV) radiation to the water toreduce levels of viruses therein. The incoming water then passes throughvalve 116 and enters fluid-circulation system 100. Valves 214 and 216 indrain line 212 are in an open position to allow any air trapped infilter element 300 to flow out drain line 212. After a predeterminedamount of time, valves 214 and 216 in drain line 212 are then changedfrom an open position to a closed position. The incoming water is thenfiltered by filter element 300 within system feeder line 122. Uponexiting filter element 300, 75 to 100% of the flow passes along branchfeeder line 124 and flows through heater 132 and valve 125 and thenproceeds to fill fluid-circulation system 100, the deactivation chamber,and instrument container 800. Initially valve 158 is an open position toallow any air in the lumens of the medical instruments and other devicesto exit into the instrument container 800. After a predetermined amountof time valve 158 is changed from an open position to a closed position.

The incoming water is under pressure from an external source and forceswater in fluid-circulation system 100, the deactivation chamber, andinstrument container 800. As a result of water entering the apparatus10, air within the system will migrate toward overflow line 292 that ispreferably disposed at the highest point of apparatus 10. Directionalcheck valve 293 allows air and water to exit the decontaminationchamber. The presence of water flowing through overflow line 292 issensed by sensor 294. Water flowing through drain line 292 is indicativethat apparatus 10 is filled. The system controller then causes valves104 and 116 to close, thereby stopping the flow of water into apparatus10. The foregoing description basically describes the fill phase of adecontamination cycle.

Circulation Phase

Once apparatus 10 is filled with water, the system controller initiatesa circulation phase to circulate water throughout fluid-circulationsystem 100. During the circulation phase, valves 254 and 276 tochemistry-delivery system 400 remain closed and valve 125 remains opento allow heated fluid from branch feeder line 124 to flow into fluidcirculation system 100, the deactivation chamber, and instrumentcontainer 800. Pumps 172 and 182 are energized to circulate waterthroughout fluid-circulation system 100, including the deactivationchamber and instrument container 800.

FIG. 6 schematically illustrates the flow of fluid throughoutfluid-circulation system 100 during the circulation phase. The purposeof the circulation phase is to achieve the proper fluid temperature todeactivate the medical devices in the instrument container. At periodsthroughout the fill phase and the circulation phase, heater 132 may beactivated to increase the temperature of the water flowing through theheater to achieve a desired fluid temperature in the system. Once thedesired fluid temperature is achieved, the circulation phase ends.

Chemistry-Generation Phase

Following the circulation phase, valves 254 and 276 tochemistry-delivery system 400 are opened to allow the flow of watertherethrough. Initially, valve 258 within section 252 a of thechemistry-inlet line 252 is closed such that water initially flows intosection 252 b of chemistry-inlet line 252, wherein the water is directedinto housing 470 of chemistry-delivery system 400 and, morespecifically, into compartment 484 containing the builder components.More specifically, water flows into second inlet passage 496 withinhousing 470 and up through opening 564 and passage 562 in seal element542 into cavity 554 defined in seal element 542. As best illustrated inFIG. 17, water flows through apertures 578 in plate 544 into thebuilders to dissolve the same. The builder components within container434 of chemistry-holding device 430 dissolve in the water and flowthroughout the fluid-circulation system 100. Valve 266 in drain line 264is closed, thereby preventing the deactivation fluid from drainingthrough drain opening 508 through the bottom of compartment 484.Accordingly, fluid will fill compartment 484 and flow out of compartment484 through overflow passage 262 b into section 264 b of outlet line262. In this respect, compartment 484 will be filled with fluid up tooutlet line 262 b. Chemistry-housing outlet line 262 b connects tochemistry-outlet line 262 that, in turn, connects to return line 162,wherein the dissolved builders enter the re-circulation system to bepumped throughout fluid-circulation system 100. The dissolution ofbuilder components creates an alkaline fluid having a predetermined pHlevel. In one embodiment, the pH level is between about 8.0 and about9.0. In accordance with one embodiment of the present invention, byflowing water at a known flow rate through compartment 484 containingbuilder components, an alkaline fluid with a predetermined pH level iscreated at a predetermined time. The predetermined time is programmedinto the system controller. The predetermined time is sufficient togenerate an alkaline fluid having a predetermined pH level during eachdecontamination cycle. It is also contemplated that a sensor may be usedto determine when an alkaline fluid having a predetermined ph level hasbeen produced.

Once an alkaline fluid having a predetermined pH level is produced,valve 258 is opened to allow water to flow through container 432 in thechemistry-holding device 430. Because the apertures 576 are larger thanapertures 578, the flow rate through apertures 576 will be 1 to 10%higher than the flow rate through apertures 578. Preferably, the flowrate through aperture 576 will be 3 to 7% higher than the flow ratethrough apertures 578. Ideally, the flow rate through aperture 576 willbe 5% higher than the flow rate through aperture 578. In this respect,the flow rate through compartment 484 containing builder components willbe lower than the flow rate through compartment 482 containing achemical reagent. The ratio of flow rate through compartment 482 to theflow rate through compartment 484 is chosen to achieve optimalgeneration of a microbial deactivation fluid. In the embodimentheretofore described, container 432 preferably contains acetylsalicylicacid. When the dissolved builder components contact the acetylsalicylicacid, a microbial deactivation fluid is generated. As with container434, water flowing through container 432 fills compartment 482 inhousing 470 and exits chemistry-delivery system 400 through section 262a of chemistry-return line 262. In this respect, compartment 482 will befilled with fluid up to outlet line 262 a. FIG. 7 generally illustratesthe fluid flow through fluid-circulation system 100 during thechemistry-generation phase. As illustrated in FIG. 7, the microbialdecontamination fluid will ultimately flow through sterilant sensor 142that monitors the concentration thereof to ensure that a proper level ofthe decontaminating solution is within the fluid.

Exposure Phase

During the exposure phase, the microbial deactivation fluid formed inthe chemistry-generation phase is conveyed throughout fluid-circulationsystem 100 as schematically illustrated in FIG. 8. The microbialdeactivation fluid flowing through first- and second-branch feeder lines124, 126 flow into the decontamination chamber and into instrumentcontainer 800 therein. The deactivation fluid flowing into instrumentcontainer 800 is sprayed through spray nozzles 852 around the exteriorof the medical instruments within container 800. Fluid flowing throughbranch feeder line 124 flows into cavity 874 within tray 812 and throughconnectors 848 into the lumens and passages within medical instruments842. In this respect, deactivation fluid circulates through thedecontamination chamber formed by drawer tray 622 and plate 642 andflows out of the chamber to return line 162. Similarly, fluid flows outof instrument container 800 through a return conduit to return line 162.During the exposure period, pumps 172 and 182 continuously pump fluidthroughout fluid-circulation system 100. Pump 172 is the high-pressurepump that provides sufficient pressure to force deactivation fluidthrough filter element 300, heater 132, second branch feeder line 126,and through chemistry-delivery system 400. In a preferred embodiment,pump 172 is capable of pumping fluid at about 3.5 gallons per minute atabout 40 psig. At these levels, there is sufficient force to flowthrough the restrictive filter element 300, lumen passages withinmedical instruments 842, heater 132 and chemistry-delivery system 400.Pump 172 is capable of pumping about 25% of the total fluid flow in thesystem. Pump 182, i.e., the high-volume pump, provides a larger amountof fluid at lower pressure to the decontamination chamber and theinterior of instrument container 800. Pump 182 is capable of pumpingabout 75% of the total fluid flow in the system. Higher pressure fluidflowing through second branch feeder line 126 provides a lower volumebut a higher pressure fluid and is connected to lumen passages withinmedical instruments 842 within instrument container 800. During theexposure phase, deactivation fluid is circulated throughoutfluid-circulation system 100 and through the deactivation chamber andinstrument container 800 for a pre-determined period of time. It issufficient to decontaminate items within the instrument container and todecontaminate the components and fluid conduits of fluid-circulationsystem 100.

Drain Phase

After a pre-determined exposure period, the system controller initiatesa drain phase. The drain phase is comprised basically of two steps, bestseen in FIGS. 9A and 9B. During the drain phase, valves 254 and 276 tothe chemical-delivery system are closed to prevent flow thereto. Valves147, 198, and 274 in drain lines 146, 196, and 272, respectively, areopened. Pumps 172, 182 continue to operate for a pre-determined periodof time, forcing the deactivation fluid in the decontamination chamberand instrument container 800 out through drain lines 146, 196, asillustrated in FIG. 9A. At the same time, valves 284, 286, are opened toconnect chemistry-inlet line 252 to water-inlet line 102. Valve 104 isthen opened to allow water to enter the system and flushchemistry-delivery system 400 as schematically illustrated in FIG. 9A.Water entering chemistry-delivery system 400 is drained fromchemistry-delivery system 400 through drain line 272. In this respect,during the drain phase, fluid entering chemistry-delivery system 400 isnot allowed to enter any portion of fluid circulation system 100 that isdownstream of valve 276 or upstream of valve 254. After a pre-determinedperiod of time sufficient to allow flushing of chemistry-delivery system400 and after a period sufficient to allow draining of most of the fluidfrom fluid circulation system 100 through pumps 172, 182, pumps 172 and182 are deactivated. Valve 104 is closed to stop the flow of water tochemistry-delivery system 400. Valve 286 in connecting line 282 is thenclosed. Air line 288 is connected to a source of filtered, dry,pressurized air that enters the chemistry-delivery system 400 throughconnecting line 282 and chemistry-inlet line 252. The air essentiallyblows the remaining water within chemistry-delivery system 400 outthrough drain line 272 and further dries the interior portions ofchemistry-delivery system and the lines connecting thereto. In thisrespect, during the drain phase, air entering chemistry-delivery system400 is not allowed to enter any portion of fluid circulation system 100that is downstream of valve 276 or upstream of valve 254. As illustratedin FIG. 9A, valve 266 in drain line 264 is opened to allow compartments482, 484 within housing 470 of chemistry-delivery system 400 to drainfrom the bottom. Similarly, pressurized, dried air is applied to airline 152 and, thus, is conveyed through the lower portion offluid-circulation system 100 to blow out remaining fluid within theinternal passages of the medical devices in the device container.

Once the drain phase has been completed, an indication is provided onthe display panel 28 of housing structure 22. If a valve element 894 wasinstalled into each connector inserts 692C, 692B, 692C, then actuator908, schematically illustrated as a pin in FIGS. 25 and 26, moves valveelement 894 from an open position to a closed position. At that time,the air pressure to bladder 646 is removed and springs 647 bias plate642 and static seal 644 away from the surface of drawer tray 622. Drawerassembly 600 may then be moved to an open position by pressingdrawer-activation button 634. With drawer assembly 600 in an openposition, instrument container 800 can be removed from drawer tray 622.If container 800 includes valve element 894, or in the alternative, avalve element 1240, barrier 898 or filter element 1280, respectively,will prevent microbial decontamination of the interior of instrumentcontainer 800.

Storage of Instrument Container(s) 800

In accordance with one aspect of the present invention, the deactivatedinstruments may remain within instrument container 800 and may be storedfor a pre-determined period of time, with the instruments in instrumentcontainer 800 remaining in a microbially deactivated environment. Inthis respect, instrument container 800 would be inserted into acompartment 1014 of storage cabinet 1000. Instrument container 800 wouldbe inserted into a compartment 1014, wherein connections on the bottomof instrument container 800 engage and mate with connector 1026A, 1026B,1026C on shelf 1022 of storage cabinet 1000.

As illustrated in the drawings, a plurality of instrument containers 800may be inserted into storage cabinet 1000, with each instrumentcontainer 800 being in communication with the warm, air-circulationsystem.

The foregoing description is a specific embodiment of the presentinvention. It should be appreciated that this embodiment is describedfor purposes of illustration only, and that numerous alterations andmodifications may be practiced by those skilled in the art withoutdeparting from the spirit and scope of the invention. It is intendedthat all such modifications and alterations be included insofar as theycome within the scope of the invention as claimed or the equivalentsthereof.

1. In an apparatus for deactivating medical instruments and devices having a circulation system for circulating a fluid through a decontamination chamber for holding medical instruments and devices, a method of generating a microbial deactivation fluid and exposing said devices to said microbial deactivation fluid for an instrument exposure period of time comprising the steps of: (a) providing a first compartment and a second compartment in said circulation system; (b) providing a chemical reagent in said first compartment and a builder composition in said second compartment; (c) causing a fluid to flow through said second compartment to begin dissolving said builder composition to create an alkaline fluid that is conveyed through said decontamination chamber; (d) circulating said alkaline fluid through said second compartment and said decontamination chamber until said alkaline fluid has reached a predetermined pH level, then causing said alkaline fluid to flow through said first compartment to begin dissolving said chemical reagent to generate a microbial deactivation fluid; (e) continuing steps (c) and (d) to continue the generation of said microbial deactivation fluid; and (f) maintaining the concentration of said microbial deactivation fluid flowing through said decontamination chamber at a predetermined concentration for an instrument exposure period of time by continuously flowing said fluid at a first flow rate through said first compartment and at a second flow rate through said second compartment during said instrument exposure period of time such that the ratio of said first flow rate to said second flow rate results in optimal generation of said microbial deactivation fluid during said instrument exposure period of time.
 2. A method as defined in claim 1, further comprising the step of: (g) causing said microbial deactivation fluid to flow through said decontamination chamber at a predetermined temperature.
 3. A method as defined in claim 2, wherein said predetermined temperature is between about 50° C. and about 60° C.
 4. A method as defined in claim 1, wherein said predetermined pH level is between about 8.0 and about 9.0.
 5. A method as defined in claim 1, wherein said predetermined minimum concentration of said microbial deactivation fluid is between about 1250 ppm and about 2000 ppm.
 6. A method as defined in claim 1, wherein said chemical reagent is acetylsalicylic acid.
 7. A method as defined in claim 1, wherein said builder composition includes a per-salt.
 8. A method as defined in claim 7, wherein said per-salt is sodium perborate.
 9. In an apparatus for deactivating medical instruments and devices having a circulation system for circulating a fluid through a decontamination chamber for holding medical instruments and devices, a method of generating a microbial deactivation fluid comprising the steps of: (a) providing a first compartment and a second compartment in said circulation system; (b) providing a chemical reagent in said first compartment and a builder composition in said second compartment; (c) causing said fluid having a temperature between about 45° C. and about 60° C. to flow through said second compartment to begin dissolving said builder composition to create an alkaline fluid in said decontamination chamber; and (d) when said alkaline fluid in said decontamination chamber has reached a predetermined pH level, causing said alkaline fluid to flow through said first compartment to begin dissolving said chemical reagent to generate a microbial deactivation; (e) maintaining the concentration of said microbial deactivation fluid flowing through said decontamination chamber at a predetermined concentration for an instrument exposure period of time by continuously dissolving said chemical reagent at a first rate and said builder composition at a second rate during said instrument exposure period of time.
 10. A method as defined in claim 9, further comprising the step of: (f) causing said microbial deactivation fluid to flow through said decontamination chamber at a predetermined temperature.
 11. A method as defined in claim 10, wherein said predetermined temperature is between about 50° C. and about 60° C.
 12. A method as defined in claim 9, wherein said predetermined pH level is between about 8.0 and about 9.0.
 13. A method as defined in claim 9, wherein said chemical reagent is acetylsalicylic acid.
 14. A method as defined in claim 9, wherein said builder composition includes a per-salt.
 15. A method as defined in claim 14, wherein said per-salt is sodium perborate.
 16. In an apparatus for deactivating medical instruments and devices having a circulation system for circulating a fluid through a decontamination chamber for holding medical instruments and devices, a method of generating a microbial deactivation fluid comprising the steps of: (a) providing a first compartment and a second compartment in said circulation system; (b) providing a chemical reagent in said first compartment and a builder composition in said second compartment; (c) causing said fluid to flow through said second compartment to begin dissolving said builder composition to create an alkaline fluid in said decontamination chamber; (d) when said alkaline fluid in said decontamination chamber has reached a predetermined pH level, causing said alkaline fluid to flow through said first compartment to begin dissolving said chemical reagent to generate a microbial deactivation fluid; and (e) maintaining the concentration of said microbial deactivation fluid flowing through said decontamination chamber at a predetermined concentration for an instrument exposure period of time by continuously dissolving said chemical reagent at a first rate and said builder composition at a second rate during said instrument exposure period of time.
 17. A method as defined in claim 16, wherein said predetermined pH level is between about 8.0 and about 9.0.
 18. A method as defined in claim 16, wherein said chemical reagent is acetylsalicylic acid.
 19. A method as defined in claim 16, wherein said builder composition includes a per-salt.
 20. A method as defined in claim 19, wherein said per-salt is sodium perborate.
 21. In an apparatus for deactivating medical instruments and devices having a circulation system for circulating a fluid through a decontamination chamber for holding medical instruments and devices, a method of generating a microbial deactivation fluid comprising the steps of: (a) providing a first compartment and a second compartment in said circulation system; (b) providing a chemical reagent in said first compartment and a builder composition in said second compartment; (c) causing said fluid to flow through said second compartment to begin dissolving said builder composition to create an alkaline fluid in said decontamination chamber; (d) after a predetermined amount of time, causing said alkaline solution to flow through said first compartment to begin dissolving said chemical reagent to generate a microbial deactivation fluid; and (e) maintaining the concentration of said microbial deactivation fluid flowing through said decontamination chamber at a predetermined concentration for an instrument exposure period of time by continuously dissolving said chemical reagent at a first rate and said builder composition at a second rate during said instrument exposure period of time.
 22. A method as defined in claim 21, wherein said predetermined amount of time is based on said alkaline solution achieving a predetermined pH level.
 23. A method as defined in claim 22, wherein said predetermined pH level is between about 8.0 and about 9.0.
 24. A method as defined in claim 21, wherein said chemical reagent is acetylsalicylic acid.
 25. A method as defined in claim 21, wherein said builder composition includes a per-salt.
 26. A method as defined in claim 25, wherein said per-salt is sodium perborate.
 27. A method as defined in claim 2, further comprising the steps of: h) fluidly isolating said first compartment and said second compartment from said circulation system; i) conveying a rinse water through said first compartment and said second compartment to remove residual microbial deactivation fluid therefrom; and j) conveying a pressurized air through said first compartment and said second compartment to remove said rinse water therefrom.
 28. A method as defined in claim 1, wherein said first flow rate is faster than said second flow rate.
 29. A method as defined in claim 1, wherein said first flow rate causes said chemical reagent to dissolve at a first rate and said second flow rate causes said builder composition to dissolve at a second rate. 